Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization
TRACE-AF
1 other identifier
interventional
100
1 country
2
Brief Summary
A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2017
CompletedFirst Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJune 18, 2019
June 1, 2019
3.5 years
August 2, 2017
June 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rehospitalization Recurrence of AF
Rate of rehospitalization after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation, Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation
in 12 months follow up
Study Arms (2)
Conventional follow up
OTHERConventional follow up at physician practice
Telemetric smartphone application
EXPERIMENTALStructured follow up with a telemetric smartphone application
Interventions
Structured follow up with a telemetric smartphone application
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Written informed consent
- symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation)
- cryoballoon pulmonary vein isolation
- possession of a compatible smartphone
You may not qualify if:
- Age \< 18 years
- persistent or permanent atrial fibrillation (AF)
- prior catheter or surgical ablation of AF
- pregnant females
- contraindication for oral anticoagulation
- manifest hyper-/hypothyroidism
- no intention to cooperate
- alcoholism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Asklepios St Georg
Hamburg, 20246, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Meyer, MD
Universitaeres Herzzentrum Hamburg GmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2017
First Posted
August 31, 2017
Study Start
July 15, 2017
Primary Completion
December 31, 2020
Study Completion
June 30, 2021
Last Updated
June 18, 2019
Record last verified: 2019-06